Events

Recall of Device Recall Navigation and Visualization systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by OEC Medical Systems, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30758
  • Event Risk Class
    Class 2
  • Event Number
    Z-0689-05
  • Event Initiated Date
    2004-12-13
  • Event Date Posted
    2005-04-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36539
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Image Processing, Radiological - Product Code LLZ
  • Reason
    Enhanced sterility testing revealed the sterilization efficacy of accessories ('sensors') used with certain navigation and visualization systems may be compromised.
  • Action
    Customers were notified by letter on 12/13/04.

Device

Device Recall Navigation and Visualization systems
  • Model / Serial
    The particular accessories (''Sensors'') involved are: Short Range Transmitter (P/N 1004587 or 1002008); Snap Receiver Cable (P/N 1004069 or 1001989); Extended Range Transmitter (P/N 1004070 or 1003991); and T-Handle Spine Tool Receiver (P/N 1004072).
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic distribution: Nationwide, including 4 military facilities and 4 VA facilities. Foreign distribution: Canada.
  • Product Description
    FluroTrak 9800 Plus Navigation and Visualization System
  • Manufacturer
    OEC Medical Systems, Inc

Manufacturer

OEC Medical Systems, Inc
  • Manufacturer Address
    OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA